Effect of Low Frequency Ultrasound on Kidney Function
Evaluation of the Effect of Low Frequency Therapeutic Ultrasound (LOTUS) on Kidney Function in Chronic Kidney Disease
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2013
CompletedFirst Posted
Study publicly available on registry
January 3, 2014
CompletedStudy Start
First participant enrolled
January 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2014
CompletedApril 22, 2021
April 1, 2021
8 months
December 19, 2013
April 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glomerular Filtration Rate (GFR)
Absolute change in glomerular filtration rate, GFR, measured by Tc-99m DTPA (diethylenetriamine pentaacetic acid) imaging (Gates Method) in the treated kidney(s) from baseline to during LOTUS
Baseline and 15 minutes after start of Intervention
Secondary Outcomes (2)
Percent change in GFR
Baseline and 15 minutes after start of Intervention
Blood Pressure
Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention
Other Outcomes (2)
Cutaneous Injury
5 minutes after LOTUS intervention
Heart rate
Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention.
Study Arms (1)
Low Frequency Therapeutic Ultrasound
EXPERIMENTALLow Frequency Therapeutic Ultrasound (LOTUS) applied transcutaneously
Interventions
29 kHz (kilohertz) low frequency therapeutic ultrasound delivered transcutaneously
Eligibility Criteria
You may qualify if:
- Must be \>/= 18 years of age
- Must have documented Stage 3 to Stage 4 (eGFR 15 - 59) chronic kidney disease
- Females with childbearing potential must not be pregnant at the time of study
- Subject must provide written informed consent
You may not qualify if:
- Unable or unwilling to cooperate with study procedures
- Currently enrolled in another clinical study for which the follow-up period is not complete
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonogenixlead
Study Sites (1)
Department of Radiology and Biomedical Imaging, UCSF
San Francisco, California, 94107, United States
Related Publications (1)
Dae MW, Liu KD, Solomon RJ, Gao DW, Stillson CA. Effect of Low-Frequency Therapeutic Ultrasound on Induction of Nitric Oxide in CKD: Potential to Prevent Acute Kidney Injury. Kidney Dis (Basel). 2020 Nov;6(6):453-460. doi: 10.1159/000509819. Epub 2020 Aug 21.
PMID: 33313066RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Randall A Hawkins, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2013
First Posted
January 3, 2014
Study Start
January 28, 2014
Primary Completion
October 6, 2014
Study Completion
October 6, 2014
Last Updated
April 22, 2021
Record last verified: 2021-04